MAUDE Adverse Event Report: HTL-STREFA, INC DROPLET PEN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Underdose (2542)

Event Type  Injury  

Event Description

Patient reports droplet brand pan needles are difficult to use to inject insulin.He is not sure if he is getting the right dose since they are hard to push and leak.These poorly made pen needles are preventing this patient from appropriately dosing his insulin.Symptoms: inappropriate insulin administration, potential under-dosing.

• Brand Name: DROPLET PEN
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA, INC
• MDR Report Key: 8363119
• MDR Text Key: 137261195
• Report Number: MW5084246
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR